Urgent need for increasing access to TB diagnosis – what can we learn from HIV and COVID-19

By guest contributors Gopal Panta, Lisa Stevens, and Irinn Vinaiphat

Too many people continue to die from tuberculosis (TB) every year, the number one infectious disease killer. Despite recovery in case finding and treatment post-COVID, the world is far from the World Health Organization (WHO) goal to end TB by 2035, with recent dramatic reductions in global TB funding further worsening the situation. Every year 10.8 million people, including 1.3 million children, become ill from TB and 1.25 million die – 2.6 million never learning that they have it and never starting treatment. In addition to reaching all in need, powerful game-changing innovations – including novel diagnostics, better treatment, and a vaccine – are greatly needed.

Despite advances in TB diagnosis from smear microscopy to more sensitive near point-of-care molecular tests with drug-resistance information, access remains limited due to costs, availability, power backup, maintenance issues, and continued reliance on sputum samples, which can be difficult to obtain, especially in children. Unless machines are brought to the community through focused campaigns, people with TB or their sputum must travel to a machine. Usually more than one visit is required for diagnosis and treatment initiation.

Compare this to HIV and COVID-19 where patients themselves or lay workers can perform rapid diagnostic tests that are simple, inexpensive, accessible anywhere even in communities and homes, and require no laboratory infrastructure or technicians. The sample, blood or oral fluid for HIV and nasal or nasopharyngeal fluid for COVID-19, is always obtainable unlike sputum, stool, or biopsies required for TB. Rapid diagnostics give results in only about twenty minutes so people can immediately start treatment and help prevent transmission to others.

HIV diagnosis transitioned from complex tests (e.g. ELISA) requiring laboratory infrastructure to simple, highly accurate, blood- or oral swab-based, readily available rapid tests. These have been extensively used to find HIV in community settings, hard-to-reach populations and among high-risk groups and to treat people immediately, contributing greatly to the progress towards HIV epidemic control.  

The COVID-19 pandemic proved that with adequate effort, will and resources, new rapid diagnostic tools can be rapidly developed. Testing quickly transitioned from reference-laboratory-based testing to PCR in major hospitals to the first rapid antigen test receiving emergency use authorization in only two months after pandemic declaration. With massive public awareness through traditional and social media, these tests rapidly became highly utilized household tools around the world.

TB programs can learn from the successful scale-up of rapid diagnostics for HIV and COVID-19. Thankfully, a new point-of-care TB molecular test is now in sight with several products intended for primary care in the development pipeline, with some in late stage. Studies on those using tongue or oral swab molecular testing show promising results. Even newer molecular techniques, such as CRISPR-based tests, raise hopes for simple testing methods, including self-tests and the use of alternate samples, such as blood.

Now is the time to prepare for introduction and rapid scale-up of soon-to-be-available TB diagnostic tools. National TB programs, partners and donors need to be actively setting-up for success, including through learning from their own country’s response to HIV and COVID-19. Trust must be built among public health managers, healthcare workers, lay-workers and the public around both the new tools themselves and new specimen types. Examining HIV programs’ experience with resistance or skepticism while introducing oral swab testing in contrast to blood testing is prudent. Public awareness raising around this issue will also be extremely important.

All people with TB need access to accurate drug resistance testing to ensure individuals initiate the correct treatment. Until a pan-TB treatment regimen becomes available, the chosen regimen needs to match the specific TB strain.  Careful planning by national TB programs will be required to ensure this, especially with decentralization of testing and treatment. Therefore, it is crucial to prioritize inclusion of resistance testing in future TB tests, wherever they are performed. In addition, supply chain management and reporting systems need adaptation to decentralized and community-based testing models and should be carefully planned, executed and monitored.

With the introduction of both HIV and COVID rapid testing, some countries struggled with regulatory processes for approval. After global research assures us of efficacy and safety and global bodies (i.e., WHO) endorse the techniques and products, TB programs should accelerate adoption and minimize lengthy country-specific validation trials. Organizations and authorities involved in approving alternate specimens and tools should expedite the process and support countries to adopt, roll-out and scale-up new diagnostics efficiently.

The anticipated new point-of-care TB diagnostic tools have the potential to revolutionize TB programs and accelerate countries towards ending TB. Similar transitions to simpler and available testing modalities were extremely successful in both HIV and COVID-19 programs with much to learn from those endeavors. Now is the time to begin to lay the groundwork so that new technology can be rapidly scaled-up to benefit those affected by TB.

About the authors

Irinn Vinaiphat is a creative lead with over 15 years of experience in design for social change. She sees design as a powerful tool for change—one that can shift perspectives, spark action, and make a real impact. She currently works at FHI 360 as Director for Design Lab Asia-Pacific region. She specializes in purpose-driven design, storytelling, and brand strategy for projects across the world, making sure creativity serves a higher purpose.

Disclaimer: Views expressed by contributors are solely those of individual contributors, and not necessarily those of PLOS.

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